Medical diseases of the eye--as well as eye surgery, such as refractive surgery--can create post-operative visual disturbances for the patient. Because of this post-operative risk of visual disturbance, informed consent from the patient to the doctor is essential. As part of the presently practiced method of informed consent required from the prospective patient prior to surgery, the doctor describes to the patient what visual anomalies to expect as a result of the surgery. This description is open to subjective interpretation by the patient, and in many instances the information conveyed to the patient by the doctor is inadequate and is misinterpreted by the patient.
Significant visual distortions may commonly occur with cataracts and macular degeneration which, respectively, are the leading causes of treatable and non-treatable blindness in the United States. These diseases affect millions of patients and the visual difficulties suffered by the patients are sometimes difficult for medical personnel and the families of patients to understand and to appreciate.
Additionally, new refractive procedures, radial keratotomy (RK) and its related surgery, astigmatic keratotomy (AK) and excimer laser photorefractive keratectomy (PRK), are being performed on growing numbers of patients. Radial keratotomy (RK) and excimer laser photokeratotomy (PRK) are the dominant surgeries for the correction of refractive errors of the eye. It is estimated that approximately 300,000 to 500,000 RK procedures were performed in the U.S., and 250,000 to 300,000 PRK procedures were performed world wide during the year 1993. These surgeries are performed to correct myopia (nearsightedness) and astigmatism. Alone, myopia affects at least thirty percent of the population of the U.S. and higher proportions of the population in Far Eastern countries. PRK is also undergoing clinical trials, and approximately one million myopes will undergo PRK yearly in the U.S. once the procedure is finally approved by the FDA. PRK also shows promise for the correction of hyperopia (farsightedness).
Other refractive procedures are undergoing development which may extend the applicability of refractive surgery. These procedures include intra-lamellar corneal rings, automated lamellar keratectomy (ALK), intrastromal photoablation and "flap and zap" (ALK combined with PRK). All of the foregoing refractive procedures have the potential for reducing visual acuity and/or creating optical aberrations. Obtaining good (and legal) preoperative informed consent from patients undergoing these procedures, especially where there is an increasing amount of advertising relating to such surgery, is necessary and important. This is so because there is potential for postoperative permanent visual degradation from glare and loss of contrast sensitivity. Unmet patient expectations can create disappointment and anger and can lead to malpractice suits, even when good post-operative results are obtained. The healing response may influence the shape of the cornea in ways that are not predictable on a case by case basis. Moreover, the healing process, after surgery generally tends to fill in the cornea with new collagen, reversing some of the effects of the surgery. This healing may result in an irregular front surface of the cornea, producing, at times, visual distortion.